At the same time, two women in the ICON7 study died of complications attributed to Avastin, one from a brain hemorrhage and one from a perforated bowel. In both studies, significantly more women taking Avastin experienced hypertension — a known adverse effect of the drug.
Burger said oncologists need to weigh these risks against the modest benefits when considering whether to prescribe Avastin.
Extending life a major goal
In cancer drug research, extending the life span is the gold standard the FDA wants to see.
The FDA approved Avastin in 2004 as the first in a much-heralded class of “biological” drugs designed to squelch cancer by cutting off a tumor’s blood supply. The idea worked wonderfully in lab mice, but making it work in patients has proved challenging.
Kidney cancer patients benefit the most from Avastin. But in more common cancers, such as lung and colorectal cancer, “the beneficial effect really remains modest,” said Yihai Cao, a cancer biologist at the Karolinska Institute in Stockholm. “At the end of the day, you spend huge amounts of money, and the question is do you buy a longer life or a better life? It’s a key question — and a very hard question.”
Last month, the FDA took the unusual — and controversial — step of removing a preliminary approval for Avastin for advanced breast cancer. The agency’s head, Margaret A. Hamburg, said the risks of Avastin outweighed the benefits. The ruling drew sharp criticism from patient advocates, but long-term studies had found that the drug did not increase survival times.
Genentech, which is owned by Swiss drug giant Roche, is looking to avoid a similar episode with Avastin for ovarian cancer. “Based on the current data, there is a low likelihood that we’ll ask [FDA] for approval,” said Arnold, the Genentech spokeswoman.
Because the FDA has approved Avastin for treatment of other cancers, physicians are free to use it as they see fit, and some prescribe it for women whose ovarian cancer has recurred or returned after shrinking. Medicare pays for Avastin for recurrent ovarian cancer, as do many large insurance companies.
But in the absence of specific FDA approval, it’s unlikely that insurance companies will pick up the substantial tab of Avastin for initial ovarian cancer. The drug costs about $99,000 per year per patient.
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